(45 days)
Not Found
No
The device description focuses on mechanical components and filtration, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a reconstitution and dispensing device for preparing medications, not for directly treating a patient.
No
The device is described as a reconstitution and dispensing device for chemotherapy and IV drugs, used prior to patient administration. Its function is to facilitate the preparation and withdrawal of medication from vials, not to diagnose medical conditions.
No
The device description clearly details physical components such as filters, housing, spikes, and ports, indicating it is a hardware device.
Based on the provided information, neither the Chemo-Spike II Reconstitution Device nor the Dispensing-Spike II Device are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of both devices is for the preparation and dispensing of medications (chemotherapy drugs or IV medications) from vials prior to patient administration or physician use. This is a process related to drug handling and administration, not diagnostic testing performed on samples taken from the human body.
- Device Description: The descriptions focus on the physical components and function of the devices in facilitating the transfer of fluids (diluent or medication) into or out of vials, including venting and filtration for safety and sterility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays
These devices are clearly intended for use in the preparation and handling of medications, which falls under the category of medical devices used in the administration of treatment, not diagnostic testing.
N/A
Intended Use / Indications for Use
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.
The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining asseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.
Product codes
IHI, FMF
Device Description
Chemo-Spike II Reconstitution Device: The Chemo-Spike II Reconstitution Devices has been designed for preparing and dispensing lyophilized chemotherapy drugs in vials. The device offers a sterile vent pathway, filtering the air, as well as a filtered pathway for the actual diluent or medication. The sterile vent protects the health care practitioner by releasing the vacuum from the drug vials during reconstitution with diluent. It also protects the patient by filtering microprecipitates and crystallizations. from the diluent after reconstitution. The Chemo-Spike II Reconstitution Device consists of 2 filter media, a 5 micron hydrophilic filter for the actual medication (i.e. fluid) pathway and a 0.2 micron hydrophobic filter for venting the air pathway. Both filters are manufactured from PTFE (polytetrafluoroethylene) membrane and are housed in molded acrylic. The effective filtration area for the medication measures 1.0 cm2 while the effective vent area measures 4.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
Dispensing-Spike II Device: The Dispensing-Spike II has been designed for preparing and dispensing multiple dose I.V. medication stored in rubber-stoppered vials. It is equipped with a sharp piercing spike and tight luer lock port with a hinged cap. The technician pierces the medication vial just once with the spike. A syringe, without a needle, should be affixed to the luer lock port. Repetitive injections into or aspirations from the multiple dose I.V. vial are made through the port of the spike device. This reduces the number of times the diaphragm of the vial is pierced. The Dispensing-Spike II is equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway. The sterile vent protects the health care practitioner by helping to release the vacuum from the drug vials during reconstitution with diluent. The Dispensing-Spike II is manufactured from PTFE (mentioned above) and molded acrylic. The effective filtration area measures 1.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
PRODUCTS AND SYSTEMS FOR THE HEALTH CARE COMPLEX
Mailing Unlimited EXTEM-PREP™ SYSTEMS PS® Inc. Modi-Date® Inc. Summary of Safety and Effectiveness
JAN - 8 1998
Chemo-Spike® II Reconstitution Device Name of Device:
Catalog Number: IV5002
Classification: Chemo Dispensing/Mixing accessories would most likely have been reviewed by the FDA General Hospital Panel, Code 80, product code assignment 80FMF. This product would most likely be categorized as an accessory to a syringe, according to 21 CFR 880.5860.
Summary Statement
The Chemo-Spike II Reconstitution Devices has been designed for preparing and dispensing lyophilized chemotherapy drugs in vials. The device offers a sterile vent pathway, filtering the air, as well as a filtered pathway for the actual diluent or medication. The sterile vent protects the health care practitioner by releasing the vacuum from the drug vials during reconstitution with diluent. It also protects the patient by filtering microprecipitates and crystallizations. from the diluent after reconstitution.
The Chemo-Spike II Reconstitution Device consists of 2 filter media, a 5 micron hydrophilic filter for the actual medication (i.e. fluid) pathway and a 0.2 micron hydrophobic filter for venting the air pathway. Both filters are manufactured from PTFE (polytetrafluoroethylene) membrane and are housed in molded acrylic. The effective filtration area for the medication measures 1.0 cm2 while the effective vent area measures 4.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
The Chemo-Spike II Reconstitution Device is the predicate device granted 510(k) #K941020, manufactured by Gelman Sciences, Inc. Gelman Sciences, Inc. is the actual subcontractor of this product. The Chemo-Spike II Reconstitution Device is to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness.
1
PRODUCTS AND SYSTEMS FOR THE HEALTH CARE COMPLEX
EXTEM-PREP™ SYSTEMS Mailing Unlimited Summary of Safety and Effectiveness
Dispensing-Spike II Device Name of Device:
IV2052 Catalog Number:
Classification: I.V. Dispensing/Mixing accessories would most likely have been reviewed by the FDA General Hospital Panel, Code 80, product code assignment 80FMF. This product would most likely be categorized as an accessory to a syringe, according to 21 CFR 880.5860.
Summary Statement
The Dispensing-Spike II has been designed for preparing and dispensing multiple dose I.V. medication stored in rubber-stoppered vials. It is equipped with a sharp piercing spike and tight luer lock port with a hinged cap. The technician pierces the medication vial just once with the spike. A syringe, without a needle, should be affixed to the luer lock port. Repetitive injections into or aspirations from the multiple dose I.V. vial are made through the port of the spike device. This reduces the number of times the diaphragm of the vial is pierced.
The Dispensing-Spike II is equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway. The sterile vent protects the health care practitioner by helping to release the vacuum from the drug vials during reconstitution with diluent.
The Dispensing-Spike II is manufactured from PTFE (mentioned above) and molded acrylic. The effective filtration area measures 1.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
Please note that this product has been granted 510(k) #K946190 to Gelman Sciences, Inc. of Ann Arbor, MI. Gelman Sciences is the actual subcontractor of this product. The only change between the Gelman Sciences product and the EPS product described above is the method of sterilization and packaging.
The Dispensing-Spike II Device is the predicate device granted 510(k) #K946190, manufactured by Gelman Sciences, Inc. Gelman Sciences, Inc. is the actual subcontractor of this product. The Dispensing-Spike Device is to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Braverman Director of Marketing Medi-Dose, Incorporated 1671 Loretta Avenue Feasterville, Pennsylvania 19053
JAN - 8 -
Re : K974431 Trade Name: Chemo-Spike II Reconstitution Device Requlatory Class: II Product Code: IHI Dated: November 22, 1997 Received: November 24, 1997
Dear Mr. Braverman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Braverman
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Clatrust
Tim thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
P.02
.
. Page / of /
510(k) Number (if known): K974431
Device Name: CHEMO-SPIKE II RECONSTITUTION DEVICE
DISPENSING SPIAE II DEVICE
Indications For Use:
Indication for Use of Chem
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and I no oneing of lyophilized chemotherapy drugs in multiple dose visis. The device is used to cither add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.
Indication for Use of Dispensing-Spike II Device
The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining asseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrice Crescenti
(Division Sign-Off)
Division of Dental, Infection C and General Hospital D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)